Examples of using Sofosbuvir in English and their translations into Slovak
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Ciclosporin(600 mg single dose)/ sofosbuvir(400 mg single dose)f.
Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
No clinically relevant pharmacokinetic differencesdue to gender have been identified for sofosbuvir or GS-331007.
Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
In May 2014,he started a regimen of the recently approved Sovaldi(sofosbuvir), which he took through early November 2014.
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The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient infected with genotype 3.
No clinically relevant pharmacokinetic differences due to gender orrace have been identified for sofosbuvir and GS-331007.
The SVR12 rate in the sofosbuvir+ ribavirin treatment group was statistically significant when compared to placebo(p< 0.001).
Co-administration of Epclusa with oxcarbazepine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of Epclusa.
Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
In studies HPC3017(OPTIMIST-1) and HPC3018(OPTIMIST-2), patients received simeprevir+ sofosbuvir for 8 weeks(HPC3017 only) or 12 weeks(HPC3017 and HPC3018)(see table 11).
The sofosbuvir resistance-associated substitution S282T in NS5B was not detected in any virologic failure isolate from the Phase 3 studies.
Based on population pharmacokinetic analysis in subjects with genotypes 1 to 6 HCV infection(n= 986),steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively.
Sofosbuvir is approximately 85% bound to human plasma proteins(ex vivo data) and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
The second trial compared 12 weeks of Vosevi with the previously approved drugs sofosbuvir and velpatasvir in adults with genotypes 1, 2 or 3 who had previously failed treatment with sofosbuvir but not an NS5A inhibitor drug.
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 and GS-331007 is not an inhibitor of OAT1, OCT2 and MATE1.
Co-administration of Sovaldi with medicinal products that inhibitP-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus Sovaldi may be co-administered with P-gp and/or BCRP inhibitors.
Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in subjects with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Co-administration with medicinal products that inhibit P-gpand/or BCRP may increase ledipasvir and sofosbuvir plasma concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors.
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate(GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
FISSION was a randomised, open-label,active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 2 or 3 HCV infection.
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate(GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
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The active substance in Sovaldi, sofosbuvir, blocks the action of an enzyme called‘NS5B RNA- dependent RNA polymerase' in the hepatitis C virus, which is essential for the virus to multiply.
Dizziness has been reported during treatment with Daklinza in combination with sofosbuvir, and dizziness, disturbance in attention, blurred vision and reduced visual acuity have been reported during treatment with Daklinza in combination with peginterferon alfa and ribavirin.
Sofosbuvir is nucleotide depo-form, which after participation in the intracellular metabolism generates pharmacologically active originalului triphosphate(GS-461203), which can be entered in the RNA of hepatitis C virus NS5B polymerase and acts as the agent that breaks the chain.
The difference in the overall SVR12 rates between sofosbuvir+ ribavirin and peginterferon alfa+ ribavirin treatment groups was 0.3%(95% confidence interval: -7.5% to 8.0%) and the study met the predefined non-inferiority criterion.
Ledipasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all ledipasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.